Training Swallowing Initiation During Expiration
1 other identifier
interventional
88
1 country
2
Brief Summary
Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable head-and-neck-cancer
Started May 2022
Longer than P75 for not_applicable head-and-neck-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
July 23, 2025
July 1, 2025
4.9 years
February 8, 2022
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in frequency (%) of swallows initiated during expiration
Determines percent (frequency) of the target (expiratory phase) for each swallow.
Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Change in Penetration-Aspiration Scale scores
Measures presence, depth and reaction to penetration and aspiration.
Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 1-8 and higher scores indicate worse outcome.
Secondary Outcomes (2)
Change in Normalized Residue Ratio Scale scores
Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 0 to 100% and higher scores indicate worse outcome.
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores
Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Oral Total scores range from 0-22 and Pharyngeal Total scores range from 0-26 and higher values indicate worse outcome.
Other Outcomes (1)
Change in M.D. Anderson Dysphagia Inventory (MDADI) scores
Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 20 to 100 and higher scores indicate worse outcome.
Study Arms (2)
Respiratory-Swallow Phase Training
EXPERIMENTALParticipants will be trained to initiate swallowing during expiration.
Swallow Practice
SHAM COMPARATORParticipants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).
Interventions
Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour.
Participants will complete 6 "swallow practice" sessions that will last approximately one hour.
Eligibility Criteria
You may qualify if:
- Diagnosis of primary head and neck cancer
- Three or more months post-completion of first-line cancer treatment
- English speaking
- Functional/corrected visual and hearing acuity
- No current alcohol or other drug abuse
- Without very severe (forced expiratory volume; FEV) 1 \<30% predicted) stage Chronic Obstructive Pulmonary Disease (COPD) based on Pulmonary Function Testing (PFT)
- No skin allergy to the medical-grade sensor adhesive
- Tolerate wearing the sensor for at least 10 hours/day
- Tolerate some liquid oral intake on a routine basis
- Normal dexterity to self-administer liquids via teaspoon
- Initiation of swallowing during inspiratory phase of respiration on ≥20% of swallows
- Penetration Aspiration Scale (PAS) score ≥3 or impairment on at least one MBSImP OI score (laryngeal vestibular closure ≥1, tongue base retraction ≥2, or pharyngeal residue ≥2) on at least one swallow during lateral view of MBSS
- A PAS score of ≤6 on at least one liquid consistency without the use of a compensatory strategy or swallow maneuver
You may not qualify if:
- Persistent or recurrent cancer at the time of enrollment
- Known allergy to contrast materials or liquids used during the MBSS or training
- Known allergy to sensor adhesive
- Unable to demonstrate competency with the user-friendly technology
- Diagnosis of neurological disorders
- Indwelling tracheostomy tube
- Nasogastric (NG) feeding tube
- History of aspiration pneumonia within the past 12 months
- Unable to self-administer liquid boluses
- Unable to swallow some liquids without a maneuver
- Likely or currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Northwestern Memorial Hospitalcollaborator
Study Sites (2)
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Northwestern University
Evanston, Illinois, 60208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonnie Martin-Harris, PhD
Northwestern Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcome assessors will be naive to experimental condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 8, 2022
First Posted
March 14, 2022
Study Start
May 19, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share